search
Back to results

Use of Acupuncture for Stimulation of Labour

Primary Purpose

Dystocia

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acupuncture og acupressure when diagnosed with dystocia
Sponsored by
Herning Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystocia focused on measuring dystocia, stimulation, acupuncture, oxytocin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Normal pregnancy In labour (orificium < 8 cm), 37th week or thereafter Ruptured membranes Primary or secondary inertia - Exclusion Criteria: Pathological pregnancy Pathological labour Medical diseases Women who do not speak and undrestand danish

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    use of oxytocin
    number of contractions/30 minutes

    Full Information

    First Posted
    January 18, 2006
    Last Updated
    July 1, 2008
    Sponsor
    Herning Hospital
    Collaborators
    Ringkjøbing County Research Fond, Union of Midwives Research Fond
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00279071
    Brief Title
    Use of Acupuncture for Stimulation of Labour
    Official Title
    Use of Acupuncture for Stimulation of Labour
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Terminated
    Why Stopped
    exhausted personel after a long recruiting period
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Herning Hospital
    Collaborators
    Ringkjøbing County Research Fond, Union of Midwives Research Fond

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary inertia. A randomized controlled trial including 150 pregnant women Acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of the acupuncture. The women are randomized into to groups. Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure) No treatment The women will be asked in case beginning signs of inertia, if they want to parcipitate in the trial. Inclusion criteria: Normal pregnancy In labour (orificium < 8 cm), 37th week or thereafter Ruptured membranes Primary or secondary inertia The women will just before randomization be vaginally explored and fetal heart monitored. The meassure of effect happens two hours after randomization. The midwife who measures the effect, is blinded to the treatment or lack of, and also on the including exploration. Secondary effect meassures: length of labour, use of oxytocin and number of contracions pr/min meassured twice: 1. before the randomization and again 1 hour after randomization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dystocia
    Keywords
    dystocia, stimulation, acupuncture, oxytocin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Acupuncture og acupressure when diagnosed with dystocia
    Intervention Description
    Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67
    Secondary Outcome Measure Information:
    Title
    use of oxytocin
    Time Frame
    additional need for oxytocin infusion in 1. stage and 2. stage
    Title
    number of contractions/30 minutes
    Time Frame
    number og contractions in 1st. stage and 2nd. stage

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Normal pregnancy In labour (orificium < 8 cm), 37th week or thereafter Ruptured membranes Primary or secondary inertia - Exclusion Criteria: Pathological pregnancy Pathological labour Medical diseases Women who do not speak and undrestand danish
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kjeld Rasmussen, obst. dr.med
    Organizational Affiliation
    Obstetric ward Herning and Holstebro hospitals
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Use of Acupuncture for Stimulation of Labour

    We'll reach out to this number within 24 hrs